Drugs

FDA’s MyStudies Application (App)

The U.S. Food and Drug Administration (FDA) is posting computer code and a technical roadmap that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app. The FDA MyStudies App is designed to facilitate the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries. It was developed by the FDA and private sector partners, but open source code and technical documentation are being released to the public, so the app and patient data storage system can be reconfigured by organizations conducting clinical research.  The app bore the FDA brand while its functionality was tested in a pilot study, but it can now be rebranded by researchers and developers who would like to customize and rebrand the app.

The FDA MyStudies App has several important features, including: 

  • The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight. 
  • The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users.  
  • The data storage environment is partitioned to support multi-site trials or “distributed database” studies. 
  • The code for MyStudies will be open source so software developers can improve upon its capabilities. 

Open source code is being released for two versions of the app. One is built on Apple’s ResearchKit (iOS) framework, and the other is built on the open source ResearchStack framework, which runs on Google’s Android.  (The original FDA-branded app is not currently in app stores because it was removed after being tested in a pilot study.)

MyStudies App Technical Documents

Upcoming Releases

Additional open source code built on the Apple ResearchKit (iOS) framework and the ResearchStack framework for Google’s Android operating system will be released over the next several calendar quarters. These enhancements will simplify configuration for researchers and improve the experience for participants.  Additional details can be found in the Mobile App Quick Overview for Research document.  Please see the Sentinel website for more information on the “FDA-Catalyst MyStudies App Alignment with Pragmatic Trials and/or Registries” project.

Page Last Updated: 11/06/2018
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